E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
non small cell lung cancer |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate long term safety data (SAEs and AEs) |
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E.2.2 | Secondary objectives of the trial |
To evaluate clinical benefit as assessed by the investigator. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
• Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
• Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
• Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
Other protocol defined inclusion criteria may apply. |
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E.4 | Principal exclusion criteria |
• Patient has been permanently discontinued from ceritinib study
treatment in the parent study due to any reason.
• Patient currently has unresolved toxicities for which ceritinib dosing
has been interrupted in the parent study. (Patients meeting all other
eligibility criteria may be enrolled once toxicities have resolved to allow
ceritinib dosing to resume.)
• Pregnant or nursing (lactating) women, where pregnancy is defined
as the state of a female after conception and until the termination of
gestation, confirmed by a positive serum hCG laboratory test.
• Women of child-bearing potential, defined as all women
physiologically capable of becoming pregnant, unless they are using
highly effective methods of contraception.
• Sexually active males unless they use a condom during intercourse
while taking drug and after stopping ceritinib and should not father a
child in this period.
Other protocol defined exclusion criteria may apply.
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency and severity of AEs/SAEs |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The assessment of safety will be based on the frequency of adverse events (AEs) and serious adverse events (SAEs) |
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E.5.2 | Secondary end point(s) |
Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Brazil |
China |
Colombia |
Hong Kong |
Japan |
Korea, Republic of |
Lebanon |
Malaysia |
New Zealand |
Singapore |
Taiwan |
Thailand |
United States |
France |
Poland |
Sweden |
Bulgaria |
Spain |
Czechia |
Germany |
Italy |
Belgium |
Russian Federation |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study will occur after all patients in the study have completed their last assessment per protocol. The last assessment for each patient is the safety follow-up visit that occurs 30 days after the patient’s last dose of study treatment or until SAE follow up is resolved as required, whichever is later. See protocol for additional details. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |